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Enrolling By Invitation
NCT07839195
Effect of Post-Radiofrequency Corticosteroid Injection on the Incidence of Post-Neurotomy Neuritis
Conditions: Facet Joint Pain, Arthropathy, Sacroiliac Joint Dysfunction, Post-neurotomy Neuritis, Chronic Pain
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: Yes
Phase: PHASE2
Enrollment: 126
Sponsor: Siriraj Hospital
Location: Siriraj pain clinic, Department of Anesthesiology, Faculty of Medicine Siriraj hospital Bangkok
Summary
The purpose of this study is to compare the incidence of post-neurotomy neuritis (PNN) in adult patients undergoing radiofrequency neurotomy (RFN) for spine facet and sacroiliac joint pain, comparing those who receive a local corticosteroid injection after the procedure with those who do not. Participants are randomly assigned to receive either local anesthetic with dexamethasone or local anesthetic alone at the treatment sites. Pain scores, functional disability, and adverse events are evaluated before the procedure and at 4 weeks follow-up.
Eligibility Criteria
Inclusion Criteria:
1. Adult patient who aged equal and over 18 years old
2. Patient who scheduled for cervical, thoracic, and lumbar medial branch RFN and sacral lateral branch RFN
3. Patient who communicated effectively, demonstrated good understanding of questions and provided appropriate responses
Exclusion Criteria:
1. Contraindications to corticosteroids: Patients with a known allergy or hypersensitivity to dexamethasone or other glucocorticoids
2. Contraindications to local anesthetics: Patients with a history of severe allergic reactions to amide-type local anesthetics (e.g., bupivacaine)
3. Active Infection: Presence of localized infection at the planned injection site or systemic infection (sepsis) that may contraindicate the procedure
4. Coagulopathy: Patients with uncorrected bleeding disorders or those unable to safely discontinue anticoagulant/antiplatelet medications according to standard procedural guidelines
5. Pregnancy or Lactation: Pregnant or breastfeeding women, due to potential risks associated with radiation (fluoroscopy) and medication exposure
6. Recent Corticosteroid Exposure: Patients who have received systemic or local corticosteroid injections at the target site within the past 3 months, which may interfere with the study outcomes
7. Unstable Neurological Conditions: Patients with progressive neurological deficits or acute radiculopathy that requires urgent surgical intervention
Source: ClinicalTrials.gov (NCT07839195). StuddyBuddy aggregates publicly available trial information.